Nikolas Burlew

Since 1992 Nik has worked in the biotechnology, renewable energy and pharmaceutical development fields. His experience includes manufacturing and process development, including pharmaceutical quality assurance, quality system development and implementation, auditing and inspections in both GMP and GLP environments. In addition to preparing CMC documentation in support of new and investigational drug applications, he has had hands-on Industry experience in the production of API, bulk sterile biologics and solid oral dose pharmaceuticals. Nik received his BA degree in Environmental, Population and Organismic Biology from the University of Colorado and is currently teaching courses on GMP for Pharmaceuticals at Colorado State University as part of the Regulatory Affairs Program in the School of Biomedical Engineering.